Status:
COMPLETED
Study to Investigate Safety and Tolerability Single Ascending Doses of AZD4017.
Lead Sponsor:
AstraZeneca
Conditions:
Healthy
Eligibility:
MALE
20-45 years
Phase:
PHASE1
Brief Summary
The primary aim of this study is to investigate the safety and tolerabilty of AZD4017 when given as single oral ascending doses to Japanese healthy male volunters. This will be done by comparing the e...
Eligibility Criteria
Inclusion
- Provision of signed written and dated informed consent
- BMI between 19 and 27 kg/m2
- Subjects must be willing to use barrier methods of contraception
Exclusion
- History of any clinical significant disease
- Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product
- History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
- Laboratory blood sample result showing elevated liverenzymes (ASAT, ALAT) and muscle enzymes (CK).
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00799747
Start Date
December 1 2008
End Date
April 1 2009
Last Update
July 2 2009
Active Locations (1)
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1
Research Site
Fukuoka, Japan